Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

Patients who require initial pre-dilatation using the study device, and then undergo
definitive therapy using additional PTCA catheters and stents, according to standard of care
will be enrolled in this study.

A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated
using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm
dilatation catheters for pre-dilatation and will complete the study within the U.S. This
equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with
the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.

Inclusion Criteria:

- At least 18 years of age;

- Willing and able to provide informed consent;

- Willing and able to meet all study requirements;

- Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions
in coronary arteries that are amenable to percutaneous coronary interventions;

- Patients who tolerate DAPT

Exclusion Criteria:

- A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin,
anti-platelet medications, or sensitivity to contrast media, which cannot be
adequately pre-medicated;

- LVEF < 30%;

- Evidence of an acute myocardial infarction within 72 hours of the intended index
procedure;

- Planned treatment of unprotected left main disease;

- History of cerebral vascular accident (CVA) within 6 months prior to consideration for
this study;

- Transient ischemic attack (TIA) within 6 months prior to consideration for this study;

- Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to
consideration for this study;

- History of bleeding diathesis or coagulopathy;

- Refuses blood transfusions;

- Any general contraindication to revascularization procedures;

- Pregnant or lactating;

- In the judgement of the investigator, patient is not a suitable candidate for this
study.